Coverage Policy Manual
Policy #: 2003063
Category: Surgery
Initiated: December 2003
Last Review: July 2018
  Cryosurgical Ablation of Pancreatic Cancer

Description: Cryosurgical ablation (hereafter, cryosurgery) involves freezing of target tissues, most often by inserting into the tumor a probe through which coolant is circulated. Cryosurgery may be performed as an open surgical technique or as a closed procedure under laparoscopic or ultrasound guidance.

The hypothesized advantages of cryosurgery include improved local control and benefits common to any minimally invasive procedure (e.g., preserving normal organ tissue, decreasing morbidity, decreasing length of hospitalization). Potential complications of cryosurgery include those caused  by the hypothermic damage to normal tissue adjacent to the tumor, structural damage along the probe track, and secondary tumors, if cancerous cells are seeded during probe removal.

Pancreatic cancer is a relatively rare solid tumor that occurs almost exclusively in adults and is almost always fatal. Surgical resection of tumors contained entirely within the pancreas is currently the only potentially curative treatment. However the nature of the cancer is such that few tumors are found at such an early and potentially curable stage.  Patients with more advanced local disease or metastatic disease may undergo chemotherapy with radiation following resection. This is rarely curative but rather seeks to retard tumor growth or palliate symptoms.

There is no specific CPT code describing cryosurgical ablation of pancreatic tumors.

Policy/
Coverage:
Cryosurgical ablation of pancreatic tumors is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For contracts without primary coverage criteria, cryosurgical ablation of pancreatic tumors is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.

Rationale:
This policy was originally based on an analysis of relevant literature identified in a MEDLINE/PubMed search performed in July 2003. The literature search identified publications discussing application of cryosurgery for primary and metastatic tumors outside the liver and prostate. All were uncontrolled case series with varied criteria to select patients for cryosurgery, and reported limited data on long-term outcomes. Cryosurgical treatment of other tumors has been attempted, but evidence on outcomes of these uses is limited to isolated case reports.
 
The following section summarizes those studies that adequately described baseline characteristics of the patient populations and the methods used for cryosurgery, and also reported outcomes of treatment for 8 or more patients with the same diagnosis, or 8 or more procedures on the same malignancy. One article  discussed cryosurgery in 429 patients with a wide variety of primary and recurrent solid tumors (e.g., head and neck, lung, genital organs, sarcomas). Although the author reported survival for some patient subsets with certain of these malignancies, the article only reported baseline tumor and patient characteristics for those with breast cancer.
 
Kovach et al reported 10 cryosurgical ablations in 9 patients with unresectable pancreatic cancer using intraoperative ultrasound guidance during laparotomy. The authors report no intraoperative morbidity or mortality and that all patients had adequate pain control postoperatively. At the time of publication, all patients were dead at an average of 5 months postoperatively (range: 1–11 months). Because this pilot feasibility study did not include a control group or compare outcomes of cryosurgery to alternative strategies for managing similar patients, no conclusions are possible on effects of cryosurgery for pancreatic cancer.
 
2008 Update
Review of peer reviewed medical literature published July 2005 through August 2008 found only two articles, by the same author, describing the same patients, which describe a prior study covering I125 and cryosurgery in 49 and 38 patients with locally advanced pancreatic cancer (Xu, et.al.).  There were no controls.  The results of this therapy on these patients does not change the policy decision.
 
2011 Update
A literature search was conducted through July 2011.  Li and colleagues reported on a retrospective study of 142 patients with unresectable pancreatic cancer treated with palliative bypass with (n=68) or without cryoablation (n=74) from 1995 to 2002 (Li, 2011). Median dominant tumor sizes decreased from 4.3 cm to 2.4 cm in 36 of 55 patients (65%) 3 months after cryoablation. Survival rates were not significantly different between groups, with the cryoablation group surviving a median of 350 days versus 257 days in the group that did not receive cryoablation. Complications overall were not significantly different between the 2 groups. However, a higher percentage of delayed gastric emptying occurred in the cryoablation group compared to the group that did not receive cryoablation (36.8% vs. 16.2%, respectively).
 
This information does not prompt a change in the coverage statement.
 
2012 Update
A literature search conducted through September 2012 did not reveal any new randomized controlled trials that would prompt a change in the coverage statement.  In 2012, Tao and colleagues reported on a systematic review of cryoablation for pancreatic cancer (Tao, 2012). The authors identified 29 studies from the literature search and included 5 of these studies in the review. The 5 studies were all case series and considered to be of low quality. Adverse events, when mentioned in the studies, included delayed gastric emptying (0% to 40.9% in 3 studies), pancreatic leak (0% to 6.8% in 4 studies), biliary leak (0% to 6.8% in 3 studies), and one instance of upper gastrointestinal hemorrhage. Pain relief was reported in 3 studies and ranged from 66.7% to 100%. Median survival times reported in 3 studies ranged from 13.4 to 16 months. One-year total survival rates reported in 2 studies were 57.5% and 63.6%.
 
2013 Update
A literature search was conducted using the MEDLINE database through September 2013.  No new information was identified that would prompt a change in the coverage statement. One relevant study, described below, was identified.
 
2014 Update
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
One systematic review was identified by Keene and colleagues on ablation therapy for locally advanced pancreatic cancer in 2014 (Keene, 2014). The review noted studies have demonstrated ablative therapies, including cryoablation, are feasible but larger studies are needed. No conclusions could be made on whether ablation resulted in better oncologic outcomes than best supportive care.
 
2015 Update
A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Pancreatic Cancer
Kovach et al reported on 10 cryosurgical ablations in 9 patients with unresectable pancreatic cancer using intraoperative ultrasound guidance during laparotomy (Kovach, 2017)The authors reported adequate pain control in all patients postoperatively and no intraoperative morbidity or mortality. At publication, all patients had died at an average of 5 months postoperatively (range, 1-11 months).

References: Keane MG, Bramis K, Pereira SP et al.(2014) Systematic review of novel ablative methods in locally advanced pancreatic cancer. World J Gastroenterol 2014; 20(9):2267-78.

Kovach SJ, Hendrickson RJ, Cappadona CR, et al.(2002) Cryoablation of unresectable pancreatic cancer. Surgery. Apr 2002;131(4):463-464. PMID 11935137

Kovach SJ, Hendrickson RJ, et al.(2002) Cryoablation of unresectable pancreatic cancer. Surgery 2002; 131:463-4.

Li J, Chen X, Yang H et al.(2011) Tumour cryoablation combined with palliative bypass surgery in the treatment of unresectable pancreatic cancer: a retrospective study of 142 patients. Postgrad Med J. 2011; 87(1024):89-95.

Tang K, Yao W, Li H, et al.(2014) Laparoscopic renal cryoablation versus laparoscopic partial nephrectomy for the treatment of small renal masses: a systematic review and meta-analysis of comparative studies. J Laparoendosc Adv Surg Tech A. Jun 2014;24(6):403-410. PMID 24914926

Tao Z, Tang Y, Li B et al.(2012) Safety and Effectiveness of Cryosurgery on Advanced Pancreatic Cancer: A Systematic Review. Pancreas 2012; 41(5):809-11.

Xu KC, Niu LZ, Hu YZ, et.al.(2008) A pilot study on combination of cryosurgery and 125 iodine seed implantation for treatment of locally advanced pancreatic cancer. World J Gastroenterology, 2008; 14:1603-1611.

Xu KC, Niu LZ, Hu YZ, et.al.(2008) Cryosurgery with a combination of (125) iodine seed implantation for treatment of locally advanced pancreatic cancer. J Dig Dis, 2008; 9:33-40.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2019 American Medical Association.